Commission Regulation (EC) No 256/2009 of 23 March 2009 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for azoxystrobin and fludioxonil in or on certain products (Text with EEA relevance)

of 23 March 2009

amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for azoxystrobin and fludioxonil in or on certain products

(Text with EEA relevance)

Preamble

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC ¹ , and in particular Article 14 (1) (a) thereof,

Whereas:

(1) For azoxystrobin and fludioxonil maximum residue levels (MRLs) were set in Annexes II and III to Regulation (EC) No 396/2005 respectively. As regards azoxystrobin, in the context of a new authorisation in accordance with Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market ² for use of that plant protection product on turnips, an application has been made for a modification of the existing MRL in accordance with Article 6(1) of that Regulation. As regards fludioxonil an application for an import tolerance MRL in accordance with Article 6(2) and (4) of Regulation (EC) No 396/2005 was made by an applicant in a third country (the United States) in which the authorised use of that plant protection product leads to residues exceeding the MRL for pomegranates, as set out in Annex III to that Regulation.

(2) Both applications were evaluated in accordance with Article 8 of that Regulation and Portugal and Denmark forwarded evaluation reports to the Commission.

(3) The European Food Safety Authority, hereinafter ‘the Authority’, assessed the safety of the proposed MRLs taking into account the information in the applications and the evaluation reports and gave reasoned opinions. It forwarded these opinions [in accordance with Article 10 of the Regulation] to the Commission and the Member States and made them available to the public ³ .

(4) The Authority concluded in its reasoned opinions that all requirements with respect to data were met and that the two modifications to the MRLs requested by the applicants were acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. It took into account the most recent information on the toxicological properties of the substances. Neither the lifetime exposure to both substances via consumption of all food products that may contain the two substances, nor the short-term exposure due to extreme consumption of turnips or pomegranates showed that there is a risk that the acceptable daily intake (ADI) or the acute reference dose (ARfD) is exceeded.

(5) Based on the reasoned opinion of the Authority and taking into account the factors relevant to the matter under consideration, the requested modifications to the MRLs fulfil the requirements of Article 14(2) of Regulation (EC) No 396/2005.

(6) Regulation (EC) No 396/2005 should therefore be amended accordingly.

(7) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health and neither the European Parliament nor the Council has opposed them,

HAS ADOPTED THIS REGULATION:

Article 1

Annexes II and III to Regulation (EC) No 396/2005 are amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union .

Final provisions

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 23 March 2009. For the Commission Androulla VASSILIOU Member of the Commission

¹ OJ L 70, 16.3.2005, p. 1 .

² OJ L 230, 19.8.1991, p. 1 .

³ EFSA scientific reports (2008) 199 and 200 on http://efsa.europa.eu

Annexes II and III to Regulation (EC) No 396/2005 are amended as follows:

(1) Annex II is amended as follows:

The lines for azoxystrobin are replaced by the following:

‘Pesticide residues and maximum residue levels (mg/kg)

(2) Annex III is amended as follows:

The lines for fludioxonil are replaced by the following:

‘Pesticide residues and maximum residue levels (mg/kg)

¹ For the complete list of products of plant and animal origin to which MRLs apply, reference should be made to Annex I.

Indicates lower limit of analytical determination.

Pesticide-code combination for which the MRL as set in Annex III Part B applies.’

² For the complete list of products of plant and animal origin to which MRLs apply, reference should be made to Annex I.

Indicates lower limit of analytical determination.’

Footnotes

1. For the complete list of products of plant and animal origin to which MRLs apply, reference should be made to Annex I. ↩ ↩² ↩³ ↩⁴

2. For the complete list of products of plant and animal origin to which MRLs apply, reference should be made to Annex I. ↩ ↩² ↩³ ↩⁴

3. EFSA scientific reports (2008) 199 and 200 on http://efsa.europa.eu ↩ ↩²